🇺🇸 Motrin in United States

15,393 US adverse-event reports

Marketing authorisation

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Drug Ineffective — 2,166 reports (14.07%)
  2. Pain — 2,054 reports (13.34%)
  3. Nausea — 1,931 reports (12.54%)
  4. Headache — 1,785 reports (11.6%)
  5. Fatigue — 1,410 reports (9.16%)
  6. Vomiting — 1,387 reports (9.01%)
  7. Off Label Use — 1,214 reports (7.89%)
  8. Drug Hypersensitivity — 1,176 reports (7.64%)
  9. Dizziness — 1,153 reports (7.49%)
  10. Diarrhoea — 1,117 reports (7.26%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Motrin approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Motrin in United States?

Alkermes, Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.